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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. BULK PACK TRANSDUCER PROTECTOR PROTECTOR, TRANSDUCER, DIALYSIS

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ERIKA DE REYNOSA, S.A. DE C.V. BULK PACK TRANSDUCER PROTECTOR PROTECTOR, TRANSDUCER, DIALYSIS Back to Search Results
Catalog Number 04-9500-2
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2017
Event Type  Malfunction  
Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

 
Event Description

A clinic manager from a hemodialysis (hd) patient's facility reported during hd treatment the transducer protector came loose from the dialysis lines and experienced blood loss during the event. Additional follow-up revealed the transducer protector came loose one hour after treatment was initiated. The estimated blood loss was 20mls. No patient injury or medical intervention was required. The patient was monitored and her vital signs remained stable. No defect or damage was observed to the transducer protector or its packaging. The patient was able to successfully complete treatment on the same machine. The sample was discarded.

 
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Brand NameBULK PACK TRANSDUCER PROTECTOR
Type of DevicePROTECTOR, TRANSDUCER, DIALYSIS
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX 88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX 88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7008581
MDR Text Key92481726
Report Number8030665-2017-00947
Device Sequence Number1
Product Code FIB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK003445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue Number04-9500-2
Device LOT Number16AR01005
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age mo
Event Location No Information
Date Manufacturer Received11/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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